Auditieve stimulatie-effecten op slaap en geheugen bij patiënten met epilepsie
Effecten van auditieve stimulatie op gecoördineerde non-REM-slaaposcillaties en geheugen bij epilepsiepatiënten met geïmplanteerde hippocampale elektroden
This study will investigate the role of coordinated brain rhythms during sleep in memory consolidation and determine whether playing precisely timed brief bursts of noise can enhance these rhythms and improve memory in epilepsy inpatients with implanted hippocampal electrodes.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
The investigators will test the hypotheses that coordinated brain rhythms during nonrapid eye movement sleep are associated with memory consolidation and can be enhanced with auditory stimulation (playing precisely timed brief bursts of quiet noise) to improve memory. The investigators will measure differences in sleep and memory performance in epilepsy inpatients with implanted hippocampal electrodes and continuous full scalp EEG monitoring under three overnight sleep conditions: a baseline night; a memory night during which sleep-dependent memory consolidation is assessed with the finger tapping motor sequence task (MST) with training prior to sleep and testing the next morning; and a stimulation night during which participants train on the MST, have precisely timed auditory stimulation during the sleep that follows, and are tested on the MST in the morning.
Studietype
Inschrijving (Werkelijk)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
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Massachusetts
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Boston, Massachusetts, Verenigde Staten, 02114
- Massachusetts General Hospital
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
Inclusion Criteria:
- Inpatients with epilepsy
- Aged 12-65
- Undergoing clinically indicated continuous scalp and intracranial EEG monitoring with implanted hippocampal electrodes
- Fluent in English
- Able to give informed consent/assent (for minors aged 12-17 or adults with an appointed guardian)
Exclusion Criteria:
- Intellectual disability impairing ability to perform task
- Motor problems that preclude finger tapping task
- Previous surgery anticipated to disrupt coordination of sleep oscillations in the circuitry of interest
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Fundamentele wetenschap
- Toewijzing: NVT
- Interventioneel model: Opdracht voor een enkele groep
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: Epilepsy inpatients
Epilepsy inpatients with implanted hippocampal electrodes and continuous scalp EEG monitoring |
Hippocampal and scalp EEG monitoring during overnight sleep Training on the finger tapping MST prior to monitored overnight sleep with MST testing the following morning Training on the finger tapping MST prior to monitored overnight sleep that includes auditory stimulation, with MST testing the following morning |
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Changes in slow oscillation-spindle-hippocampal ripple coupling
Tijdsspanne: Three nights of sleep within three weeks
|
Changes in the coupling of slow oscillations with spindles and hippocampal ripples during non-Rapid Eye Movement (NREM) sleep as measured by scalp and intracranial EEG between baseline, memory, and auditory stimulation nights. |
Three nights of sleep within three weeks
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Changes in sleep-dependent consolidation of motor procedural memory
Tijdsspanne: Three nights of sleep within three weeks
|
Changes in sleep-dependent improvement of motor procedural memory performance on the finger tapping motor sequence task (MST) between baseline, memory, and auditory stimulation nights. Different sequences are employed for the memory and auditory stimulation nights in a counter-balanced order. |
Three nights of sleep within three weeks
|
|
Changes in slow oscillations
Tijdsspanne: Three nights of sleep within three weeks
|
Changes in slow oscillations during non-rapid eye movement (NREM) sleep as measured by EEG between the baseline, memory, and auditory stimulation nights |
Three nights of sleep within three weeks
|
|
Changes in sleep spindles
Tijdsspanne: Three nights of sleep within three weeks
|
Changes in sleep spindles during non-rapid eye movement (NREM) sleep as measured by EEG between baseline, memory, and auditory stimulation nights |
Three nights of sleep within three weeks
|
|
Changes in hippocampal ripples
Tijdsspanne: Three nights of sleep within three weeks
|
Changes in hippocampal ripples during non-rapid eye movement (NREM) sleep as measured by intracranial EEG between baseline, memory, and auditory stimulation nights |
Three nights of sleep within three weeks
|
Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Hoofdonderzoeker: Dara Manoach, PhD, Professor
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 2020P003959
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Beschrijving IPD-plan
The PI will disseminate results through presentations at public lectures, scientific institutions and meetings, and/or publications in major journals. The institution and the PI will adhere to the NIH Grants Policy on Sharing of Unique Research Resources including the Sharing of Biomedical Research Resources. Prevailing standards and guidelines in documenting and depositing data sets will be followed. Specifically, quality-controlled data used in publications will be deidentified and made available to requesting scientists, starting one year following the completion of the project. Workflows will be documented and will allow any external groups to reproduce results from the raw data. The PI will be responsible for overseeing the sharing the data. Raw and summary data will be submitted to the appropriate NIMH Data Archive annually, including The National Database for Clinical Trials Related to Mental Illness (NDCT).
IPD-tijdsbestek voor delen
Data will be available one year following the completion of the project.
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
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